Replies to post #34966 on Amarin Corp Plc (AMRN)

[The Canes]

The FDA is a tacitly professed self-governing body and once in a great while Congress calls on them to tidy up their act. No way has this event qualified for such a day of reckoning. I wish it did. On another note do you smile when you sell a stock and it just continues to plummet? I suppose it's an uncontrollable feeling of satisfaction. Do you think it brings an inner smile to J.Z. and J.T.? Oh well keep the pay checks coming.

[jessellivermore]

HD.

"A clinical protocol assessment will no longer be considered binding if the director of the review division determines that a substantial scientific issue essential to determining the safety or efficacy of the drug has been identified after the testing has begun."

I can not speak for Hungarian Law, but in the USA the foundation of the law governing this type of contract is "what a reasonable man would do." In this case even though it is not spelled out, the director of the review division can not merely claim to have found a substantial scientific issue. He must be able to convince the counter party's or the courts. No reasonable man is going to give over unchallengable right to define what is "substantial" to his counter party if the possibility exists that the counter party could unfairly use this to his own advantage.

I'm sure the courts would rule that substantial would be an issue both sides agreed on. For example, the drug causes brain cancer is a substantial number of people (safety). The placebo arm had a lower number of events than the treated.

There are several fundamental problems in the FDA's thinking. A big one is their attitude change concerning surrogate biomarkers in CVD. The FDA certainly has every right to change its mind and insist on evidence obtained from clinical outcomes. The problem is the ANCHOR SPA does not adress the question of whether or not Vascepa when added to statins will or will not raise or lower CVD risk. The SPA is not contingent on the clinical preformance of V in R-IT. The only two contigenies are V lowering trigs 15% in ANCHOR (check) and the company having R-IT substantially underway (check). The FDA apparently lost track of the fact R-IT was designed to answer something everybody knew before R-IT and that was the question if adding V to statins would lower CVD risk.

So did the trig studies shed any light on R-IT? The answer is no. They do not prove EPA will work or that it will not work. Does the FDA's new found evidence based medicine shed any light on R-IT..no.

Are the R-IT results important..yes..extremely important..If R-IT is a failure it close a very important chapter..If R-IT is wildly successful it could be one of the bigest medical breakthroughs, one that might change clinical medicine.

So what we come down to is a combat decision. What it worth..To take the hill to destroy the bridge, to find out if concentrated EPA will cut CVD risk...The FDA owed it to the company to keep their promise, owed it to themselves and to America..

":>) JL